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  5. Drug Trials Snapshots: TIVDAK
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Drug Trials Snapshots: TIVDAK

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the TIVDAK Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

TIVDAK (tisotumab vedotin-tftv)
(tiv-dak)
Seagen Inc.
Approval date: 9/20/2021


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

TIVDAK is a drug used in adults with cervical cancer. TIVDAK may be used when cancer has come back or spread to other parts of the body and chemotherapy did not work or stopped working.

How is this drug used?

TIVDAK is given into a vein in your arm (intravenous infusion) by a healthcare professional once every 3 weeks. It takes about 30 minutes to get the TIVDAK infusion.

Who participated in the clinical trials?

The FDA approved TIVDAK based on evidence from one clinical trial (NCT03438396) including 101 patients with cervical cancer that came back or had spread to other parts of the body. Chemotherapy didn’t work or had stopped working for the patients. The trial was conducted at 36 sites in Europe and the United States.

What are the benefits of this drug?

The trial measured the number of patients whose tumors completely or partially shrank with treatment with TIVDAK. In the trial, 24 of 101 patients (24%) treated with TIVDAK had tumors that completely or partially shrank, and that lasted an average of 8 months.

TIVDAK was approved under FDA’s accelerated approval program. This program lets patients take a promising new drug while the company continues clinical trials to confirm that the drug works well.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: All included patients were female; therefore, sex differences could not be determined.
  • Race: Almost all patients were White; therefore, race differences could not be determined.
  • Age: No patient aged 65 and above had complete or partial shrinkage of their tumor.

What are the possible side effects?

Eye problems are common with TIVDAK and can also be serious. TIVDAK can cause changes to the surface of your eye. These changes can lead to dry eyes, eye redness, eye irritation, damage to the cornea in the eye (corneal ulcers), blurred vision, and severe vision loss.

TIVDAK can cause serious side effects including nerve problems (peripheral neuropathy), bleeding (hemorrhage), lung problems, and harm to an unborn baby.

The most common side effects of TIVDAK include lower numbers of red blood cells and white blood cells, tiredness, upset stomach (nausea), hair loss (alopecia), nosebleed, changes in kidney function tests, dry eye, abnormal blood clotting test results, diarrhea, and rash.

Were there any differences in side effects among sex, race and age?

  • Sex: Everyone in the trial was female; therefore, sex differences could not be determined.
  • Race: Almost everyone in the trial was White; therefore, race differences could not be determined.
  • Age: Patients aged 65 years or older were more likely to experience severe or serious side effects than patients under 65 years old.

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes patients enrolled in the clinical trial by sex.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 0 (0%) male patients and 101 (100%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes patients enrolled in the clinical trial by race.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, and other patients were in the clinical trial. In total, 96 (20%) White patients, 1 (1%) Black or African American patients, 2 (2%) Asian patients, and 2 (2%) Other patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes patients enrolled in the clinical trial by age.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 88 (87%) patients younger than 65 years of age and 13 (13%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes patients enrolled in the clinical trial by ethnicity.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic and Not Hispanic patients were in the clinical trial. In total, 6 (6%) Hispanic or Latino patients and 95 (94%) Not Hispanic or Latino patients participated in the clinical trial.

Source: Adapted from FDA Review

How were the trials designed?

TIVDAK was approved based on one clinical trial. The trial enrolled 101 adults with cervical cancer whose disease came back or had spread to other parts of the body. Chemotherapy did not work or had stopped working for the patients in the trial before they got TIVDAK.

All patients got TIVDAK every 3 weeks until their cancer got worse (disease progression) or the side effects were too severe.

The trial measured how many patients treated with TIVDAK had cancer that completely or partially shrank and how long the shrinkage lasted. It also provided data on side effects.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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